Thursday, 31 March 2016

During its 154th Session, the Ph. Eur. Commission adopted a revision of its monograph for Water for Injections (0169). Up to now, the production of Water for Injections (WFI) had been limited to distillation only. The revision allows for production of WFI by a purification process equivalent to distillation such as reverse osmosis, coupled with appropriate techniques. The revised monograph will be published in the Ph. Eur. Supplement 9.1 and will become effective in April 2017.

Microbial
identification is the determination of the broad group (eg, bacteria, yeast, or
mold) or narrow group (e.g., genus and / or species) to a qui microorganism
belongs to.

Microbial
characterization is the use of colony growth, cellular morphology, differential
staining, and key diagnostic features to characterize a laboratory isolate for
trending and investigative Purposes without identification, example,
nonpathogenic Staphylococci.

Microorganisms,
if detected in drug substances, excipients, water for pharmaceutical use, the
manufacturing environment, intermediates, and finished drug products, UNDERGO typically
characterization. This May include identification and strain typing, as
considers.

In
relation to the above, Radhakrishna S. Tirumalai, Ph.D. has written an
interesting article for the magazine La Vague. The article can
be found here.

Wednesday, 30 March 2016

A
new FDA guidance document has been issued: “Revised Preventive Measures to
Reduce the Possible Risk of Transmission of CJD and Variant CJD by Blood and
Blood Products.”

Tests
are being developed to detect CJD and vCJD infections in blood and plasma donors.
However, until suitable donor screening tests become available, FDA continues
to recommend interim preventive measures based on the available scientific data
and the evolving state of knowledge regarding these diseases. FDA may update
this guidance in the future, in light of developments in testing technology, epidemiological
information, and the impact of these recommendations on the supply of blood and
blood-derived products.

Monday, 28 March 2016

A new finding puts forward a more even ratio of one-to-one for the
relationship between human cells in the body and microorganisms. To illustrate
this, the researchers took a ‘typical man’ as a reference point. Imagine a man
who weighs 70 kilograms, is aged between 20–30 years old and stands 1.7 metres
tall. This man, microbiologists Ron Milo, Shai Fuchs and Ron Sender calculate
is made up of around 30 trillion human cells and 39 trillion bacteria.

Tim Sandle explores the relationship between microorganisms and
human cells in a new article published in Microbioz
India. The reference is:

Sunday, 27 March 2016

A new species of bacteria that causes Lyme disease has
been discovered by Mayo Clinic scientists, in collaboration with the U.S.
Centers for Disease Control and Prevention. The new species is provisionally
named Borrelia mayonii. Before the
discovery, the only other species known to cause Lyme disease was an organism
called Borrelia burgdorferi.

Lyme disease is transmitted to people via the bite of a black-legged tick, called
the deer tick. The disease leads to headache, rash, and neck pain. In serve
cases it can lead to deliberating arthritis. Treatment is by antibiotics. In
recent years, the disease has spread considerably across the U.S., covering a
larger geographical area.

The discovery came about after medical researchers examined samples from U.S.
patients taken during the period 2003 to 2014. For this, a molecular biology
technique called polymerase chain reaction (PCR) was used. Of the samples
screened, 6 of 9,000 samples, taken from residents of Minnesota, North Dakota
and Wisconsin, showed a different pattern.

The differences led to the discovery of the new
organism - B. mayonii. Although the
bacterium has probably been present for some time, it has hitherto escaped
detection. As well as the classic Lyme disease symptoms, B. mayonii causes nausea and vomiting, and a different type of
rash. In addition, for those infected, the concentration of bacteria in the
blood is higher.

The research is published in the journal The Lancet Infectious Diseases, in a
paper titled ‘Identification of a novel pathogenic Borrelia species causing
Lyme borreliosis with unusually high spirochaetaemia: a descriptive study.’

Saturday, 26 March 2016

Researchers have developed a "Muscle
On-A-Chip" method to examine the best methods to repair damaged heart cells.
A clearer understanding has been obtained for stem-cell derived treatment.

Heart attacks are a very real risk as people become older. When a heart attack happens, and the person
survives, the cells that make up the heart – cardiomyocytes - are damaged. This occurs due a temporary lack of
oxygen. The damaged cells, which acts as cardiac muscle cells, weakens the patient.

There are two types of cells within the heart: the
cardiomyocytes and the cardiac pacemaker cells. Cardiomyocytes shape the fundamental
contractile units of muscle cells. Cardiac
pacemaker cells help to control the hear rate.

Due to the damage and associated risks, biomedical scientists
have examined whether heart cells can be repaired using stem cells. The theory
is that stems cells could possibly be transplanted into the wall of heart
muscle, together with native heart muscle cells, with the aim of improving
contractile function.

Progress using stem cells has been slow, due to a
number of ineffective results. The
pairing of the heart cells is structurally strong, but there is a difference
with contractile strength, with the cells made from stem-cells being weaker.

In order to assist data review, Harvard University researchers
have developed a system to measure the relationship between native heart
cardiomyocytes and stem-cell derived cardiomyocytes. The researchers have
deployed mouse models to examine the process. This has revealed that the two
cell-types (native cardiomyocytes and stem-cell derived cardiomyocytes) combine
to create “two-cell microtissue.” The researchers have dubbed this “muscle
on-a-chip.”

This has led to the finding that the differences in contractile
strength between the two cell-types is due to misdirected transmission of
mechanical forces, with forces directed outwards rather than between the
coupled cells.

The new knowledge about mechanical coupling of stem
cells and native cells provides the basis for improving the use of stem-derived
cells with an aim of improving patient outcomes.

The research findings are published inThe Journal of Cell Biology. The research paper is titled ‘Coupling
primary and stem cell–derived cardiomyocytes in an in vitro model of cardiac
cell therapy.’

Friday, 25 March 2016

Legionellosis is a collective term for diseases caused
by legionella bacteria including the most serious Legionnaires’ disease, as
well as the similar but less serious conditions of Pontiac fever and
Lochgoilhead fever. Legionnaires’ disease is a potentially fatal form of
pneumonia and everyone is susceptible to infection. The risk increases with age
but some people are at higher risk.

The bacterium Legionella pneumophila and related
bacteria are common in natural water sources such as rivers, lakes and reservoirs,
but usually in low numbers. They may also be found in purpose-built water
systems such as cooling towers, evaporative condensers, hot and cold water
systems and spa pools.

If conditions are favourable, the bacteria may grow
increasing the risks of Legionnaires’ disease.

Public Health England have produced a Legionella
isolation scheme: sample instruction sheet. This will be useful to clinical
laboratories. The sheet, available in different languages, can be found here.

Thursday, 24 March 2016

Escherichia coli (E. coli) bacteria normally live in the
intestines of people and animals. Most E. coli are harmless and actually are an
important part of a healthy human intestinal tract. However, some E. coli are pathogenic, meaning they can
cause illness, either diarrhea or illness outside of the intestinal tract. The
types of E. coli that can cause
diarrhea can be transmitted through contaminated water or food, or through
contact with animals or persons.

E. coli consists of a diverse group
of bacteria. Pathogenic E. coli
strains are categorized into pathotypes. Six pathotypes are associated with
diarrhea and collectively are referred to as diarrheagenic E. coli.

Shiga toxin-producing E. coli (STEC)—STEC may also be referred to as
Verocytotoxin-producing E. coli
(VTEC) or enterohemorrhagic E. coli
(EHEC). This pathotype is the one most commonly heard about in the news in
association with foodborne outbreaks.

Public Health England have produced a: sample
instruction sheet. This will be useful to clinical laboratories. The sheet,
available in different languages, can be found here.

Wednesday, 23 March 2016

TB in cattle is caused by the bacterium Mycobacterium bovis (M. bovis). Cattle, buffalo and bison are
the natural hosts of M. bovis, but
nearly all mammals are susceptible to the infection to a variable degree. The
organism also has the capacity to infect and cause TB in humans. However, the
risk of infection for the general public remains very low in industrialised
countries with long-standing bovine TB control programmes and where
pasteurisation of cows’ milk is either mandatory or commonly practised.

In relation to this disease, Public Health England has produced an information sheet. This will be of particular interest to those who are
involved with agriculture.

Tuesday, 22 March 2016

Bio-Rad Laboratories Inc., a life science research and
clinical diagnostic products manufacturer has joined IBM Research and Mars Inc.
in the Consortium for Sequencing the Food Supply Chain. The consortium is harnessing the power of
genomics and informatics to study microbiomes in food to help prevent
contamination and foodborne illness at any step in the food supply chain.

The consortium was initially launched by IBM and Mars
in January of 2015, and since joining the effort, Bio-Rad will contribute
expertise in chromogenic and molecular tests for food pathogens and food
quality indicators.

Monday, 21 March 2016

ISO
45001 on occupational health and safety has been approved for Draft
International Standard public consultation.

Designed
to help organizations of all sizes and industries, the future standard is
expected to reduce workplace injuries and illnesses around the world.

ISO
45001 is based on the common elements found in all of ISO’s management system
standards, assuring a high level of compatibility with the new versions of ISO
9001, Quality management systems, and ISO 14001, Environmental management
systems. It uses a simple Plan-Do-Check-Act (PDCA) model, which provides a
framework for organizations to plan what they need to put in place in order to
minimize the risk of harm.

Sunday, 20 March 2016

The
biggest challenge facing the world’s population is the shortage of
antimicrobial compounds. This has arisen due to the overprescribing of
antibiotics and other antimicrobials; as a consequence of bacterial resistance,
arising from evolutionary mechanisms or plasmid transfer, to one or more
antimicrobial compound; to add to this the threat of newly emerging pathogens
remains ever-present.

To
address these issues and to outline current research and developments in the
search for new antimicrobials, Tim Sandle has written a new paper for the Journal of Pharmaceutical
Microbiology.

Saturday, 19 March 2016

A
new draft cleanroom standard has been produced: ISO Draft International
Standard (DIS) 14644-13: Cleaning of surfaces to achieve defined levels of
cleanliness in terms of particle and chemical classification.

Guidance
is provided on the assessment of cleaning methods for achieving the required
surface cleanliness levels specified in ISO 14644-9: Classification of surface
cleanliness by particle concentration and ISO 14644-10: Classification of
surface cleanliness by chemical concentration. Different cleaning methods may
be necessary depending on the degree of cleanliness required. The selection
procedure considers aspects such as surface description, cleanliness
specifications, types of contamination, cleaning techniques, and material
compatibility. Guidance is provided on assessing cleaning efficacy.

Friday, 18 March 2016

By
sequencing genomes of a newly discovered group of microbes, the Hadesarchaea, an international team of
researchers have found out how these microorganisms make a living in the deep
subsurface biosphere of our planet. The Hadesarchaea
belong to the archaea.

To
find the microorganisms, researchers sequenced the genomes of several
Hadesarchaea. They were able to determine how these microbes should be
classified and what physiologies they use to survive under these extreme
conditions. Hadesarchaea have the ability to live in areas devoid of oxygen and
the scientists suggest that they are able to survive there by using carbon
monoxide to gain energy. Interestingly, the chemical pathways the Hadesarchaea
cells use to metabolize carbon monoxide are unique to what has been seen
before.

Thursday, 17 March 2016

Anthropologists
are studying the ancient and modern human microbiome and the role it plays in
human health and disease. By applying genomic and proteomic sequencing
technologies to ancient human microbiomes, such as coprolites and dental
calculus, as well as to contemporary microbiomes in traditional and
industrialized societies, Researchers are advancing the understanding of the
evolutionary history of our microbial self and its impact on human health
today.

Wednesday, 16 March 2016

In many tropical countries, mosquitoes can spread diseases such as dengue, chikungunya, West Nile, malaria, yellow fever and Zika. Here are ﬁve simple rules you should follow to reduce your risk of infections spread by mosquitoes.

Tuesday, 15 March 2016

The world's first public museum about all things microbial is in Amsterdam, in The Netherlands. It is called Micropia.

Micropia is the world's first museum dedicated to microbes and micro-organisms, which actually make up two-thirds of all living matter.

At a cost of €10 million, Micropia opened in October 2014 and is part of the Royal Artis Zoo complex in the Plantage district of Amsterdam.

The museum is located on Artisplein which is a public square also recently opened at Artis. On entering you can purchase tickets on the ground floor and then take the lift ride up to the first floor - as you ascend look up to watch an animation about the mites living on your eyelashes and the even smaller bacteria and viruses living on those mites!

Micropia Essential Info

Opening Times: Daily 0900-1800 (Sun-Wed) and 0900-2000 (Thu-Sat).

Admission Prices (2016): €14 for adults, €12 for children 3-9, €7.50 for students, free for children 0-2. Note that Museumkaart and Iamsterdam City Card are NOT valid at Micropia. Combined Artis+Micropia tickets are €27.50 for adults, €23.50 for children 3-9.

Getting There: Artis/Micropia can be reached from the centre of Amsterdam on foot - head towards Waterlooplein and continue further east along the Plantage Middenlaan. By public transport you can take tram 14 from Dam Square or tram 9 from Central Station to stopPlantage Kerklaan.

The book 'Cleanroom Microbiology' by Tim Sandle and R. Vijayakumar has won the PDA Distinguished Author Award 2016, as selected by PDA members.

The book is about cleanrooms and controlled environments in relation to the pharmaceutical and healthcare sectors. The book is applicable to both the sterile and non-sterile pharmaceutical sectors and its focus is upon cleanroom microbiology.

Modern approaches to contamination control place a greater emphasis upon environmental control than they do on upon monitoring. This requires an understand of risk assessment; hence risk management and contamination control strategies feature strongly in the text.

The book fills a much needed gap in the microbiology and contamination control spheres. While there are books on cleanrooms available, these focus almost entirely on the physical and rarely address microbiological risks. Similarly, there are various books on microbiology (even a few about pharmaceutical microbiology), yet these books rarely mention cleanrooms, or, where they do, give controlled environments limited coverage.

To the authors of Cleanroom Microbiology, these two domains, normally separated by different functions, are inseparable. This book is about cleanrooms and controlled environments in relation to the pharmaceutical and healthcare sectors and is applicable to both the sterile and non-sterile pharmaceutical sectors with its focus on cleanroom microbiology.

The book contains 16 chapters which cover a range of key topics. These include cleanroom standards, environmental monitoring, cleaning and disinfection, staff behaviours, understanding the microbiome of human skin, culture media, microbial identification and more.

The book has been published by PDA / DHI and details can be found here.

Monday, 14 March 2016

Bio-Rad Laboratories Inc., a life science research and
clinical diagnostic products manufacturer has joined IBM Research and Mars Inc.
in the Consortium for Sequencing the Food Supply Chain. The consortium is harnessing the power of
genomics and informatics to study microbiomes in food to help prevent
contamination and foodborne illness at any step in the food supply chain.

The consortium was initially launched by IBM and Mars
in January of 2015, and since joining the effort, Bio-Rad will contribute
expertise in chromogenic and molecular tests for food pathogens and food
quality indicators.

Sunday, 13 March 2016

Counterfeit drugs have become a major worldwide issue. These types of drugs compromise the current pharmaceutical industry in a way that is dangerous for providers and patients alike. Fake medicine often has altered potencies, which can lead to unsafe dosages and medication therapies that are simply dangerous and ineffective.

This issue is particularly prominent in Africa, due to the lack of medical infrastructure. Here is a little bit more about what counterfeit drugs are, why they are being produced, and was is being done to combat this problem.

Counterfeit Drugs

Counterfeit drugs are being produced in large quantities in Africa. Last year alone, in Ghana, 90 percent of the drug oxytocin was found to be substandard and counterfeit. The majority of these substandard drugs were found in hospital and clinic environments. A good number of these drugs were produced by Chinese manufacturers. The major problem with these drugs is that they cause patient outcomes to become unpredictable, or downright negative.

For example, counterfeit or poorly produced drugs were the cause of 100,000 deaths of children who had consumed them for protection against malaria. Because the active ingredients were not present, the drugs simply did not work. Seventy percent of medications in Africa are imported. The counterfeiting process is similar to the process for other types of manufactured products, with one key difference: the drugs are manufactured without using the appropriate levels of potent materials, and are therefore ineffective.

Why Are They Being Produced

The obvious reason why these drugs are being produced is that they make money, and at a lower cost than full-potency drugs. Because there are not very many African countries that produce the drugs on native soil, this creates an opportunity for foreign companies to gain market share in an untapped area.

Combatting Fake Drugs

Making sure these drugs are regulated is an essential effort on the part of African regulatory agencies. These agencies have beef up their efforts to ensure these drugs meet certain standards. Further, the United States Pharmacopeial Convention’s (USP) Center for Pharmaceutical Advancement and Training (CePAT) in Accra, Ghana, worked to expand its quality control testing and training capacities. The group opened a new pharmaceutical microbiology laboratory to engage in quality control efforts.

According to the World Health Organization, medical products should meet certain safety, quality and effectiveness standards. The dishonest distribution of these types of products is prohibited by the World Health Organization, yet illegal activity still occurs. Furthermore, these substandard products are dangerous for consumers, which is what motivated the WHO to prohibit their distribution. In fact, the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) was created in 2006 to reduce the manufacturing, distribution and consumption of counterfeit drugs.

Counterfeit drugs are a huge problem in Africa. These drugs cause negative health outcomes and create major gaps in the healthcare delivery system. Combatting efforts of substandard manufacturers is necessary in order to sustain the quality of the delivery system and protect the health of the African public.

Megan Nichols is a science writer who specializes in health and wellness topics. She also enjoys writing about other science fields on her blog. When she isn’t writing, Megan enjoys hiking, and stargazing.